MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. HD ENDOEYE LAPARO-THORACO VIDEOSCOPE

Model Number	LTF-VH
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, the subject device had no image.The issue occurred, during an unknown event.There were no reports of patient harm.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.E1: (b)(6) (added here due to character limitation).
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 15 years since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's reportable malfunction was confirmed.Based on the results of the investigation, it is possible that electrical stress was applied to the image sensor, causing the internal electrical circuit to fail.It is possible that there was an overcurrrent to the flow in the electrical circuit due to attaching and detaching the connector while the system was on, due to electrodes of the high-frequency device having come into contact with the endoscope, or due to the electrical contacts of the video connector were contaminated with stain or water droplets while it was connected, which may have caused a short circuit.However, the definitive root cause of the reported issue could not be determined.The instruction for use states the inspection method associated with the event in " 3.6 inspection of the endoscopic system¿ chapter 3 preparation and inspection.Olympus will continue to monitor field performance for this device.

• Brand Name: HD ENDOEYE LAPARO-THORACO VIDEOSCOPE
• Common Device Name: LAPARO-THORACO VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19596815
• Report Number: 9610595-2024-12641
• Device Sequence Number: 20955797
• Product Code: GCJ
• UDI-Device Identifier: 04953170287015
• UDI-Public: 04953170287015
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K080948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LTF-VH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown